Observational study on the effects of combining salmeterol/fluticasone and tiotropium in the treatment of chronic obstructive pulmonary disease

Abstract

Objective To observe the effects of combining salmeterol/fluticasone and tiotropium in patients combination therapy with moderate to severe stable chronic obstructive pulmonary disease (COPD).Methods Two hundreds and sixteen patients with moderate-to-severe stable COPD received 12 months of treatment randomly in one of the four treatment groups:①salmetcrol/fluticasone 50/500 μg twice daily and tiotropium 18 μg once daily (n =56,M/F:46/10),②salmeterol/fluticasone 50/500 μg twice daily (n =54,M/F:46/8),③tiotropium 18 μg once daily (n =54,M/F:44/10),④the blank control group (n ＝52,M/F:42/10),Patients did not receive any inhaled anticholinergic drugs,long acting beta2 agonists or glucocorticoid therapy.The lung function index,BODE index,quality of life,adverse drug reactions were observed to compare drug efficacy and safety before treatment and after treatment for 12 months.Results One hundred and seventy-six patients completed the 12-month treatment period:48 patients receiving salmeterol/fluticasone + tiotropium (M/F:40/8).40 patients receiving salmeterol/fluticasone (M/F:32/8).46 patients receiving tiotropium (M/F:36/10).42patients receiving nither salmeterol/fiuticasone nor tiotropium (M/F:32/10).FEV1 in the three active treatments had improved significantly above baseline.FEV1 in the combination group after the trial before inhaling salbutamol was (1.19±0.03) L,which was significantly improved compared to that salmeterol/fluticasone alone (1.13±0.01) L,tiotropium alone (1.15±0.01) L,and the blank group (1.07±0.02) L.(P ＜ 0.01).The frequency of exacerbations in the combination group was [1.0 (0-1)] times,significantly lower than that in the salmeterol/fluticasone alone[1.0(0-2)] times,tiotropium alone [1.5(0-2)] times,and blank group[2.0(0-3)] times (P ＜0.05).The use of rescue medication in the combination group was [1.0(0-1)] times,significantly decreased compared with those in the salmeterol/fluticasone alone [1.0(0-2)]times,tiotropium alone [1.0(0-2)] times,blank group [2.0(0-4)] times (P ＜0.05).The BODE score in the combination group was (6.10± 1.30),significantly lower than that in the salmeterol/fluticasone alone (6.51± 1.32),tiotropium alone (6.61 ± 1.23) and blank group (7.11± 1.35).(P ＜ 0.01).Conclusions Combination therapy with salmeterol/fluticasone and tiotropium may provide benefits,with no greater risk of side-effects in patients with moderate-to severe stable COPD as compared to salmeterol/fluticasone or tiotropium alone in the treatment of COPD. Key words: Chronic obstructive pulmonary disease; Tiotropium; Salmeterol/fluticasone